OrbusNeich is trumpeting data from a newly published study on its Genous Stent. Published in the June issue of Minerva Cardiologica, the study suggests that the Genous stent is associated with a significantly lower rate of binary restenosis compared to bare metal stents (BMS) in low-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients at six months.

Background

Genous features OrbusNeich’s patented EPC (endothelial progenitor cell) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that captures EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis. Multiple clinical studies suggest that the Genous Stent is effective for patients that are non-responsive to or cannot tolerate long-term DAPT and in this context the news that the stent performed as expected against BMS must be hugely encouraging for the company.

The 60 patient, investigator-initiated randomized study, tagged JACK-EPC, investigated the possible correlation between circulating EPCs and restenosis. Previous studies with the Genous Stent as well as drug eluting stents (DES) have shown that lower numbers of these cells might be associated with higher in-stent restenosis (ISR) and Stent Thrombosis (ST).

Results indeed showed binary restenosis rate for the Genous Stent was 13 percent compared to 26.6 percent for BMS at six months. At 12 months, the major adverse cardiac events (MACE) rate for the Genous Stent was 13.3 percent compared to 23.3 percent for BMS, and no ST was observed in either group.

Physician comments

“In this randomized study, we see that the Genous Stent is associated with less neointimal proliferation than a bare metal stent, with significantly lower restenosis and late loss observed,” said Wojciech Wojakowski, M.D., Ph.D., of the Medical University of Silesia, Poland, and corresponding author of the publication. “This combined with its favorable safety profile makes Genous an effective alternative to bare metal stents and drug eluting stents for patients with contraindications to dual antiplatelet therapy.”